The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Asahi Hollow Fiber Kidneys, Excel.
| Device ID | K833150 |
| 510k Number | K833150 |
| Device Name: | ASAHI HOLLOW FIBER KIDNEYS, EXCEL |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | ASAHI MEDICAL CO., LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-15 |
| Decision Date | 1983-11-15 |